ALPHA BIO DENTAL IMPLANT SYSTEM

ALPHA BIO DENTAL IMPLANT SYSTEM is an FDA 510(k)-cleared medical device (K063364) manufactured by Alpha-Bio Tec , Ltd.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 13, 2007. Regulation: 8.